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Anti-Mullerian Hormone (CLIA)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Ref 105-010711-00, 105-010724-00, 105-010738-00, 105-010697-00, 105-065972-00, 105-065971-00Model 105-010711-00、105-010738-00、105-018808-00、105-010697-00、105-010724-00、 105-018809-00、105-018810-00、105-018811-00

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040004S-AMH*******7J Basic UDI-DI Date12 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Anti-Mullerian Hormone (CLIA)、AMH Control
Model / Reference
105-010711-00、105-010738-00、105-018808-00、105-010697-00、105-010724-00、 105-018809-00、105-018810-00、105-018811-00, 105-010711-00, 105-010724-00, 105-010738-00, 105-010697-00, 105-065972-00, 105-065971-00
Primary DI / UDI-DI
06936415922832, 06936415922849, 06936415922856, 06936415922825, 06903053158701, 06903053158695
Basic UDI-DI
69449040004S-AMH*******7J
EMDN Code
W0102050215 Anti-mullerian hormone
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No